JDRF Encouraged by FDA Draft Guidance for Artificial Pancreas

By Thania Benios

December 10, 2011

The JDRF Artificial Pancreas Project has significantly accelerated progress toward the delivery of the first artificial pancreas (AP) systems to people with diabetes. Research progress has been exceptional with multiple studies in controlled settings demonstrating that AP systems can significantly reduce high and low blood sugar levels automatically.

For people with diabetes to realize the potential of this research, a roadmap must exist so that research can be performed in real-world settings and companies can do studies for regulatory approval. A year-and-a-half long JDRF effort to encourage the United States Food and Drug Administration (FDA) to move forward on guidance for AP research and development has produced a proposal that should allow significant progress in this direction. This is a major step closer to real-life use for these revolutionary technologies and a signal of progress in therapies for people living with type 1 diabetes (T1D).

On December 1, the FDA released draft guidance on AP systems. Based on initial review, JDRF is encouraged by the FDA draft guidance document, which provides a roadmap for moving from inpatient to outpatient trials that will evaluate the safety and efficacy of AP systems, according to JDRF president and CEO Jeffrey Brewer. “Our initial assessment suggests that these guidelines allow flexibility in the clinical requirements in a way that will advance AP trials, while ensuring their safety and effectiveness,” he said.

JDRF has been working with the FDA to advance AP technologies for some time. The FDA added AP technology to its Critical Path list in 2006, making a commitment to advance these systems, and since then has approved more than a dozen inpatient studies funded by JDRF. But until now, the pathway to AP system testing in outpatient settings and, ultimately, to commercial systems remained undefined.

Working with the FDA to provide this roadmap, JDRF in 2010 gathered a team of top clinicians to draft a set of recommendations, which JDRF submitted to FDA in March 2011. JDRF then called on its volunteers, expert researchers, clinical organizations, and Congress to demonstrate support for the AP guidelines. Thanks to the efforts of countless JDRF volunteers across the country working through JDRF’s “Promise to Remember Me Campaign,” more than 250 House members and more than 60 U.S. senators sent letters to the FDA calling on the agency to produce timely AP system clinical development guidance—a truly remarkable show of broad bipartisan support. In addition, the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators (AADE), the American Diabetes Association, and The Endocrine Society submitted letters to the FDA voicing their support of the JDRF proposal.

At the 2011 JDRF Children’s Congress in June, Charles Zimliki, Ph.D., who heads up the FDA’s AP working group, stated the agency’s commitment to releasing AP system draft guidance by December 1, 2011. By the end of November, JDRF had ongoing dialogue with the FDA, placed full-page ads in major newspapers, held a Capitol Hill press conference, and presented the issue to the diabetes community, which culminated with delivery of a petition containing more than 100,000 signatures—all of which contributed to the momentum leading up to the Dec. 1 decision.

Mr. Brewer says the FDA deserves credit and praise for the flexibility reflected in the document. In addition, he says, “this draft AP systems guidance suggests that the FDA is committed to fostering innovation and ensuring the United States remains a global leader in bringing life-saving technologies for people with type 1 diabetes to the U.S. market.”

JDRF expects further dialogue before final guidance is completed.

Artificial pancreas technologies have the potential to be one of the most revolutionary advances in treating T1D since the discovery of insulin and are a top priority for JDRF. These advanced systems will allow the millions of Americans with T1D to maintain tighter control of blood glucose levels with less of a burden to their quality of life.